ARTOS: Avelox in Complicated Skin and Skin Structure Infections

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00997997

Collaborator

(none)

6,127

Enrollment

Locations

Duration (Months)

510.6

Patients Per Site

13.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This international, prospective, non-interventional, non-controlled observational study obtains data on efficacy, safety and tolerability of Avelox treatment under daily-life treatment conditions. Specifically investigated are the improvement of clinical symptoms and the duration until infection improvement and cure.Any patient with a diagnosis of complicated skin and skin structure infection (cSSSI) treated with Avelox can be documented. The observation period for each subject covers the treatment period with Avelox. For each patient, the physician documents data at an initial visit and one or two follow-up visit(s) in line with routine practice.

Condition or Disease	Intervention/Treatment	Phase
Skin Diseases, Bacterial	Drug: Moxifloxacin (Avelox, BAY12-8039)

Study Design

Study Type:

Observational

Actual Enrollment :

6127 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

ARTOS - Avelox® in Routine Treatment of Complicated Skin and Skin Structure Infections

Study Start Date :

Oct 1, 2005

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Group 1	Drug: Moxifloxacin (Avelox, BAY12-8039) 400 mg, intravenous / oral, once daily, treatment duration at the discretion of the attending physician who must consult the local product information

Arm

Intervention/Treatment

Group 1

Drug: Moxifloxacin (Avelox, BAY12-8039)

400 mg, intravenous / oral, once daily, treatment duration at the discretion of the attending physician who must consult the local product information

Outcome Measures

Primary Outcome Measures

Efficacy: course of severity of infection, course of clinical signs and symptoms, duration until improvement, duration until recovery, duration until wound closure, overall assessment of efficacy by the physician, reuse of Avelox [last documented follow-up visit, according to the respective praxis routine]

Secondary Outcome Measures

Adverse events collection [during entire study course, according to the respective praxis routine]
Overall assessment of tolerability by the physician [last documented follow-up visit, according to the respective praxis routine]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Any patient with a diagnosis of complicated skin and skin structure infection (cSSSI) and for whom the decision was made by the attending physician to start treatment with Avelox before inclusion into and independent of the study.

Exclusion Criteria:

Exclusion criteria are those specified in the local product information.

Contacts and Locations

Locations

	City	Country
1	Many Locations	Austria
2	Many Locations	Bulgaria
3	Many Locations	Egypt
4	Many Locations	Germany
5	Many Locations	Greece
6	Many Locations	Indonesia
7	Many Locations	Korea, Republic of
8	Many Locations	Pakistan
9	Many Locations	Philippines
10	Many Locations	Saudi Arabia
11	Many Locations	Slovenia
12	Many Locations	Taiwan